Combination of phentolamine and apomorphine for the treatment of human sexual function and dysfunction

Abstract

A method of treating sexual dysfunction comprising administering a therapeutically effective amount of a combination of phentolamine and apomorphine, as well as pharmaceutical compositions and kits useful in those methods, are disclosed.

What is claimed is: 
     
       1. A pharmaceutical composition for the treatment of human sexual dysfunction comprising a therapeutically effective amount of phentolamine or a pharmaceutically acceptable salt, solvate, hydrate, crystalline polymorph form or free base thereof, and a therapeutically effective amount of apomorphine or a pharmaceutically acceptable salt, solvate or hydrate thereof, and a pharmaceutically acceptable carrier. 
     
     
       2. The composition of claim 1 wherein the phentolamine is phentolamine mesylate. 
     
     
       3. The composition of claim 1 wherein the phentolamine is phentolamine hydrochloride. 
     
     
       4. The composition of claim 1 wherein the apomorphine is apomorphine hydrochloride. 
     
     
       5. The composition of claim 1 wherein the phentolamine is phentolamine mesylate and apomorphine is apomorphine hydrochloride. 
     
     
       6. A kit comprising in separate containers in a single package, pharmaceutical compositions for use in combination to treat sexual dysfunction which comprises in one container a therapeutically effective amount of phentolamine or a pharmaceutically acceptable salt, solvate, hydrate, crystalline polymorph form or free base thereof in a pharmaceutically acceptable carrier and in a second container a therapeutically effective amount of apomorphine or a pharmaceutically acceptable salt, solvate or hydrate thereof in a pharmaceutically acceptable carrier. 
     
     
       7. A method of treating sexual dysfunction, especially male erectile dysfunction, comprising administering to a human in need of such treatment an effective amount of a combination of phentolamine or a pharmaceutically acceptable salt, solvate, hydrate, crystalline polymorph form or free base thereof, and apomorphine or a pharmaceutically acceptable salt, solvate or hydrate thereof, and a pharmaceutically acceptable carrier, wherein said phentolamine and said apomorphine are administered either substantially concurrently in separate dosage forms or combined in a unit dosage form. 
     
     
       8. The method of claim 7 wherein the phentolamine is phentolamine mesylate. 
     
     
       9. The method of claim 7 wherein the phentolamine is phentolamine hydrochloride. 
     
     
       10. The method of claim 8 wherein the apomorphine is apomorphine hydrochloride. 
     
     
       11. The method of claim 7 wherein the phentolamine is phentolamine mesylate and apomorphine is apomorphine hydrochloride.